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Advanced ESD Protected PCB Design for ISO13485 Medical Equipment
US$1.00-5.00
1 Piece
Product profile
Customization
AvailableLayers
MultilayerBase Material
FR-4Model NO.
Medical PCBACertification
RoHS, CCC, ISOCustomized
CustomizedCondition
NewProduct Name
Medical PCBAService
PCB+Assembly+ComponentsTesting Service
Electrical Testing, Flying Probe Tester, FunctionaValue-Added Services
Bom Analysis, Conformal Coating, IC ProgrammingTechnical Support
Free Dfm/a Check, Bom AnalysisPlacement Precision
±0.03mm / ±0.01mm (Chip)Transport Package
ESD Bag, Carton BoxSpecification
CustomizedTrademark
CustomizedOrigin
ChinaKey features
Medical Grade Quality: IPC-A-610 Class 2/3 standards with ISO 13485 certification for medical device applications.
Comprehensive Testing: Includes 3D SPI, 3D AOI, X-ray, Flying Probe, ICT, FCT, and Burn-in tests.
Full Traceability: Complete barcode/MES traceability for component batches, processes, and operators.
No MOQ Policy: Supports both prototype and mass production with no minimum order quantity restrictions.
Customized Services: Offers custom PCB design, assembly, and value-added services like conformal coating.
Large Capacity Production: SMT capacity of 30 million points/day and DIP capacity of 100,000 pieces/day.
Strict Confidentiality: Willing to sign NDAs compliant with local laws to protect customer data and designs.
Company profile
Business Type: Manufacturer/Factory, Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc.Average Response Time: ≤0.55h
AI-Powered supplier vetting
SummaryThe supplier appears to be an electronics and medical-device-related manufacturer with SMT, THT, coating, and functional testing facilities, seven production lines, and stated PCBA and wire-and-cable output. It supports extensive customization and reports OEM service for known brands. Quality systems are supported by multiple certifications, including ISO 9001, ISO 14001, ISO 45001, ISO 13485, IATF-16949, and IECQ QC 080000. Service procedures exist for corrective actions, customer complaints, and finished-product inspection. However, the supplier has no valid manufacturing-capacity contract with affiliated subcontractors, no overseas warehouse, showroom, agents, or branches, and reports no overseas-service countries. Financial credibility cannot be established because the provided recent financial indicators are all zero. Innovation evidence is limited: one R&D engineer is reported and no SDK is available. Customer-case evidence is limited to a general statement of OEM service for known brands.
Supplier typeThe supplier operates manufacturing facilities for SMT, THT, coating, and functional testing, with seven production lines and stated PCBA and wire-and-cable output. Its business scope includes electronic products and Class I/Class II medical-device-related activities, indicating an electronics manufacturer with medical-device-related business coverage.
CertificationsThe supplier reports ISO 9001:2015, ISO 14001:2015, ISO 45001, ISO 13485:2016, IATF-16949, and IECQ QC 080000 certifications, alongside stated quality assurance in quality-control processes. These certifications provide explicit evidence of formal quality, environmental, occupational-safety, medical-device, automotive, and hazardous-substance management systems.
After-Sales capabilityThe supplier has documented and followed procedures for corrective and preventive actions, customer complaints, and finished-product inspection. It has inventory capability and accepts FOB, CIF, CFR, and EXW quotation terms, but lacks overseas warehouses, showrooms, agents, branches, and stated overseas-service coverage.
Production capacityThe supplier reports seven production lines, SMT/THT/coating/function-testing facilities, uniform finished-product inspection instructions, inventory capability, stated PCBA and wire-and-cable output, and peak-season fulfillment within 15 workdays. A deficiency remains because there is no valid manufacturing-capacity contract with affiliated subcontractors.
Customization capabilityThe supplier explicitly supports customization from samples and designs, full and minor customization, and flexible customization. It also reports OEM service for known brands, providing direct evidence of substantial customization and contract-manufacturing capability.
Product Q&A
Q:What types of products are your PCBA services primarily targeted at?
A:
Medical devices, automotive electronics, rail transit, industrial products, new energy products, network communication products, instruments and meters, products with high process complexity, and more.
Q:What information is required for a PCBA quote?
A:
PCB details, bill of materials (BOM), and test documents.
Q:What is your minimum order quantity (MOQ)?
A:
There is no MOQ restriction. We support both prototype and volume production.
Q:Do you ensure confidentiality for suppliers' product information and design files?
A:
We are willing to sign a non-disclosure agreement (NDA) compliant with the customer's local laws and commit to maintaining strict confidentiality of all customer data.
Q:What services can you provide?
A:
Turnkey service including PCB Design, PCB FAB, Component Sourcing, PCBA, Box Building, and Packaging. Value-added services include BOM Analysis, Conformal Coating, IC Programming, and Wire Harness & Cable Assembly.
Send Inquiry
*To:
Primustron Electronics
Primustron Electronics*Content:
Supplier replies will be sent to your registered email
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